ECRAID-Prime is organised into seven Work Packages (WPs), which form the backbone to realising our objectives.
Here we introduce the WPs and the persons driving each topic:
WP 1 ORG: Management and Organisation
Encompasses the Project Management and Network Coordination (ORG) activities, including the supporting activities of central organisational, managerial and coordinating activities, for the network as a whole.
WP 2 TRIAL: ECRAID-Prime Study
To develop the master protocol for ECRAID-Prime, and oversee the selection of sites and evaluation of up to four candidate therapeutic agents (in Phase I and/or Phase II).
Alike van der Velden (UMCU), Christopher Butler (University of Oxford), Sanne van Rooij (UMCU), Marjolein van Esschoten (UMCU), Marc Bonten (UMCU), Roderick Venekamp (UMCU), Ly-Mee Yu (University of Oxford), Jane Holmes (University of Oxford), Gail Hayward (University of Oxford), Emily Bongard (University of Oxford), Johanna Cook (University of Oxford) and Beatrijs Wolters (UMCU)
WP 3 LAB: Laboratory Research
To build, maintain and train a fully operational laboratory network of sites, and develop SOPs, lab manuals and protocols for the trial.
WP 4 DATA: Data Management
To develop the project’s Data Management Plan (DMP) and a clinical trial data management strategy optimised ‘by design’ for the trial, in terms of outcome measures, data standards, data quality, and data capture.
Frank Leus (UMCU), Jacques Demotes (ECRIN) and Paula Garcia (ECRIN)
WP 5 TRAIN: Training & Capacity Strengthening
To coordinate training activities in line with the OPERATES criteria for the clinical research and laboratory network, with extra focus on earlier phase research.
Alike van der Velden, Sanne van Rooij and Marjolein van Esschoten (all UMCU)
WP 6 COM: Communication & Dissemination
To oversee Communication and Dissemination activities including engaging with key stakeholders and clinical and laboratory networks, and publishing project results to promote uptake and ensure optimal impact.
WP 7 ETHICS: Ethics Requirements
To ensure compliance with the ethics requirements set out in this work package.
Roderick Venekamp (UMCU)